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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042431
Receipt No. R000048434
Scientific Title Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis
Date of disclosure of the study information 2020/11/12
Last modified on 2020/11/12

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Basic information
Public title Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis
Acronym Effects of kinesthetic illusion induced by visual stimulation on sit-to-stand movement in patients with stroke hemiparesis
Scientific Title Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis
Scientific Title:Acronym Effects of kinesthetic illusion induced by visual stimulation on sit-to-stand movement in patients with stroke hemiparesis
Region
Japan

Condition
Condition storke
Classification by specialty
Neurology Vascular surgery Neurosurgery
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of Kinesthetic illusion induced by visual stimulation with increased exercise intensity on the sit-to-stand movement of patients with stroke hemiparesis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sit-to-stand time, weight-bearing symmetry values, trunk forward inclination angle and ankle dorsiflexion angle on the paralyzed side during sit-to-stand
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Experimental group
Kinesthetic illusion induced by visual stimulation using ankle dorsiflexion video with increased exercise intensity by adding resistance
(Intervention time: 5 minutes)
Interventions/Control_2 Control group
Kinesthetic illusion induced by visual stimulation using non-resistive ankle dorsiflexion video
(Intervention time: 5 minutes)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Mini Mental State Examination 24 points or more
2)0 points for consciousness, gaze, visual field, and attention of the National Institutes of Health Stroke Scale (NIHSS)
3)Stroke Impairment Assessment Set (SIAS) distal lower leg score of 1 or higher
Key exclusion criteria 1)Visual impairment that makes it difficult to observe movies
2)Limited range of motion that affects lower limb function
3)Severe aphasia or dementia diagnosed and unable to follow instructions
Target sample size 17

Research contact person
Name of lead principal investigator
1st name Junpei
Middle name
Last name Tanabe
Organization Kurashiki Rehabilitation Hospital
Division name Department of rehabilitation
Zip code 710-0834
Address 21, Sasaki, Kurashiki, Okayama
TEL 086-421-3311
Email mjsstfive@gmail.com

Public contact
Name of contact person
1st name Junpei
Middle name
Last name Tanabe
Organization Kurashiki Rehabilitation Hospital
Division name Department of rehabilitation
Zip code 710-0834
Address 21, Sasaki, Kurashiki, Okayama
TEL 086-421-3311
Homepage URL
Email mjsstfive@gmail.com

Sponsor
Institute Kurashiki Rehabilitation Hospital
Institute
Department

Funding Source
Organization Kurashiki Rehabilitation Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kurashiki Rehabilitation Hospital
Address 21, Sasaki, Kurashiki, Okayama
Tel 086-421-3311
Email mjsstfive@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2020 Year 11 Month 12 Day
Date of IRB
2020 Year 06 Month 12 Day
Anticipated trial start date
2020 Year 12 Month 12 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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